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A Cooking and Eating Study (ACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079845
Recruitment Status : Terminated (For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.)
First Posted : March 3, 2010
Last Update Posted : February 5, 2015
Thrasher Research Fund
Information provided by (Responsible Party):
Cara Ebbeling, Boston Children's Hospital

Brief Summary:

Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome.

Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms.

Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS.

Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting.

The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire).

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: Nutrition Education, Dietary Counseling, and Cooking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults
Study Start Date : July 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low-glycemic Load Diet Behavioral: Nutrition Education, Dietary Counseling, and Cooking
Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef

Active Comparator: Low-fat Diet Behavioral: Nutrition Education, Dietary Counseling, and Cooking
Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef

Primary Outcome Measures :
  1. Bioavailable Testosterone [ Time Frame: Baseline, 6 months ]

Secondary Outcome Measures :
  1. Other Biochemical and Clinical Signs of Hyperandrogenism [ Time Frame: Baseline, 6 months ]
    total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne

  2. Insulin Sensitivity and Beta-cell Function [ Time Frame: Baseline, 6 months ]
    frequently-sampled oral glucose tolerance test, HbA1c

  3. Risk for Cardiovascular Disease [ Time Frame: Baseline, 6 months ]
    serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure

  4. Body Weight and Composition [ Time Frame: Baseline, 6 months ]
    body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference

  5. Cyclicity of Menstrual Periods [ Time Frame: Monthly ]
  6. Quality of Life [ Time Frame: Baseline, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of PCOS.
  • Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).
  • Body mass index (BMI) at or above the 85th percentile.
  • Access to a working telephone.
  • At least one parent willing and able to participate in the intervention, only for those <18 years old.
  • Residing in predominately one household (no more than one weekend every two weeks in a secondary household).
  • Medical clearance from the physician who is treating PCOS.

Exclusion Criteria:

  • Physician diagnosis of a major medical illness or eating disorder.
  • Fasting blood glucose at or above 126 mg/dL, indicating diabetes mellitus.
  • Chronic use of any medication that may affect study outcomes.
  • Current smoking.
  • Physical, mental, or cognitive handicaps that prevent participation.
  • Sister participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079845

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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Thrasher Research Fund
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Principal Investigator: Cara B. Ebbeling, PhD, MS Boston Children's Hospital
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Responsible Party: Cara Ebbeling, Associate Director, Obesity Prevention Center, Boston Children's Hospital Identifier: NCT01079845    
Other Study ID Numbers: 10-02-0069
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Cara Ebbeling, Boston Children's Hospital:
Young Adult
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases